VEMLIDY (Tenofovir Alafenamide) Monograph – Chronic Hepatitis B Virus Treatment

Published: July 31, 2025

VEMLIDY (tenofovir alafenamide) is a prescribed, once-daily, oral tablet indicated for adults and adolescents six years and older who weigh at least 55lbs for the treatment of chronic hepatitis B virus infection with compensated liver disease.

Gilead Science Inc.’s VEMLIDY (tenofovir alafenamide) was first approved for adults by the U.S. Food and Drug Administration in 2016. The approval was expanded again in 2022 and then again in 2024 to include adolescents 12 years and older and then to include adolescents six years and older who weigh at least 55lbs, respectively.

Medication Overview:

Brand Name: VEMLIDY
Generic Name: Tenofovir alafenamide
Treatment for: Hepatitis B virus
Manufacturer(s): Gilead Sciences Inc.
FDA Approval: November 2016

Indicated Condition	Indication	Age	Date Approved
Chronic Hepatitis B Virus Infection	Indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.	Adults	November 2016
Chronic Hepatitis B Virus Infection	Indicated for the treatment of chronic hepatitis B virus (HBV) infection in pediatric patients 12 years of age and older with compensated liver disease.	12 years+	November 2022
Chronic Hepatitis B Virus Infection	Indicated for chronic hepatitis B virus (HBV) infection in pediatric patients six years of age and older and weighing at least 25 kg with compensated liver disease.	6 years+	March 2024

Warnings and Precautions:

HBV and HIV-1 coinfection: VEMLIDY alone is not recommended for the treatment of HIV-1 infection. HIV-1 resistance may develop in these patients.
New onset or worsening renal impairment: Prior to or when initiating VEMLIDY, and during treatment on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. Also assess serum phosphorus in patients with chronic kidney disease.
Lactic acidosis/severe hepatomegaly with steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

Dosage and Administration:

Testing: Prior to initiation of VEMLIDY, test patients for HIV infection. VEMLIDY alone should not be used in patients with HIV infection. Prior to or when initiating VEMLIDY, and during treatment on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. Also assess serum phosphorus in patients with chronic kidney disease.
Recommended dosage: 25 mg (one tablet) taken orally once daily with food.
Renal Impairment: VEMLIDY is not recommended in patients with estimated creatinine clearance below 15 mL per minute who are not receiving chronic hemodialysis. In patients on chronic hemodialysis, on hemodialysis days, administer VEMLIDY after hemodialysis.
Hepatic Impairment: VEMLIDY is not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.

Contraindications:

No contraindications are listed.

Drug Interactions:

VEMLIDY is a substrate of P-glycoprotein (P-gp) and BCRP. Drugs that strongly affect P-gp and BCRP activity may lead to changes in VEMLIDY absorption. Consult the full prescribing information prior to and during treatment for potential drug-drug interactions.

Adverse Reactions:

Severe Acute Exacerbation of Hepatitis B
New Onset or Worsening of Renal Impairment
Lactic Acidosis/Severe Hepatomegaly with Steatosis

The most common adverse reaction (incidence greater than or equal to 10%, all grades) is headache.

Examples of Tenofovir Alafenamide in Guidelines:

Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV

Centers for Disease Control and Prevention, 2025
“HIV NPEP Regimens: The preferred regimens for adults and adolescents without contraindications are bictegravir (BIC)/emtricitabine (FTC)/tenofovir alafenamide (TAF) (recommendation, very low certainty of evidence) OR dolutegravir (DTG) plus (tenofovir alafenamide [TAF]) OR tenofovir disoproxil fumarate [TDF]) plus (emtricitabine [FTC] OR lamivudine [3TC]) (recommendation, very low certainty of evidence).”

Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults

International Antiviral Society–USA, 2022
“Recommended for most people with HIV: Persons who acquired HIV while receiving preexposure prophylaxis with tenofovir alafenamide or tenofovir disoproxil fumarate with emtricitabine should have a blood sample for genotyping drawn prior to initiating therapy and a 3-drug regimen, preferably dolutegravir or bictegravir plus TXF/XTC, should be initiated if ART is to be started before genotype results are available (evidence rating: AIII).”

Solid Organ Transplantation in the HIV-infected Patient

American Society of Transplantation, 2019
“Treatment Considerations in the HIV-positive Transplant Recipient: Tenofovir alafenamide is preferred to tenofovir disoproxil fumerate because of its improved safety profile. (Low, Strong).”

Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States

United States Department of Health and Human Services, 2025
“After delivery, people with HBV/HIV coinfection should continue antiretroviral regimens that include drugs with anti-HBV activity: tenofovir disoproxil fumarate or tenofovir alafenamide plus lamivudine or emtricitabine (AII).”

Use of Antiretroviral Agents in Adults and Adolescents Living with HIV

United States Department of Health and Human Services, 2024
“The Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) classifies the following regimens as Recommended Initial Regimens for Most People with HIV (in alphabetical order): Bictegravir/tenofovir alafenamide/emtricitabine (AI)a. Dolutegravir/abacavir/lamivudine—only for individuals who are HLA-B*5701 negative and without chronic hepatitis B virus (HBV) coinfection (AI). Dolutegravir plus (emtricitabine or lamivudine) plus (tenofovir alafenamide [TAF] or tenofovir disoproxil fumarate [TDF])b (AI). Dolutegravir/lamivudine (AI)—except for individuals with HIV RNA >500,000 copies/mL, HBV coinfection, or when ART is to be started before the results of HIV genotypic resistance testing for reverse transcriptase or HBV testing are available.”

Please note: This article is current as of July 17, 2025. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.